CalculosisNCT06163313
Protocol No. 2016 - Calculosis- Endourology;
An observational study of Calculosis, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calculosis
- What is being tested?
- Observation of patients suffering from kidney stones who undergo endoscopic surgery
- How many people
- 15,000 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2016to 30 Sep 2066
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from kidney stones who undergo endoscopic surgery
Who may be able to join
- subjects suffering from kidney stones or tumors of the upper excretory tract >= 18 years
- signature of informed consent
Who cannot join
- subjects < 18 years
- presence of mental or physical disability that may prevent the patient from answering the questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Alessia d'Arma, MSc, 02 2643 5506, darma.alessia@hsr.it
About this study
Official title: Retrospective and Prospective Study of Patients Suffering From Nephrolithiasis Undergoing Surgery Using a Minimally Invasive Endoscopic Approach.
Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.
Read the detailed description
Clinical data will be collected from patients suffering from kidney stones before and after surgery, in order to demonstrate how the endoscopic approach can not only be effective in treating kidney stones but also reduce operative complications.
These data will be collected in a database in order to be able to perform statistical analyzes useful for demonstrating our theory.
Furthermore, data from the surgery will be collected regarding the endoscopic instruments used and the intraoperative findings (site, size, appearance of the stone), degree of calcification of the renal papillae.
All this in order to improve the therapeutic approach to patients suffering from stones and reduce the risk of recurrence over time through the identification of genetic expression patterns that predispose to the expression of the stone phenotype.
- Conditions
- Calculosis
- Being tested
- Observation of patients suffering from kidney stones who undergo endoscopic surgery
- Keywords
- calculosis, calculi, endourologia
- Medical subject headings
- Lithiasis, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of patients suffering from kidney stones who undergo endoscopic surgeryOther
Clinical data will therefore be acquired through a collection of medical history, physical examination, blood chemistry and instrumental test reports;
| Study group | Role | What they receive |
|---|---|---|
| Calculosis patients | Patients suffering from kidney stones Receives: Other: Observation of patients suffering from kidney stones who undergo endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical data
Medical history: patient's medical history, past surgical history, family medical history, social history, allergies, and medications; physical examination: vital signs, temperature examination, blood pressure, pulse, and respiratory rate blood chemistry and instrumental test reports: Serum PSA levels, conventional imaging
Measured: Baseline and after 6 months
Eating habits
Eating habits through an ad-hoc eating habits questionnaire
Measured: Baseline and after 6 months
Prostatic Function
Prostatic Function through the International Prostatic Symptoms Score questionnaire, IPSS, Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms.
Measured: Baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start17 Sep 2016
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2066 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
- Investigators
- Andrea Salonia, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163313
- Sponsor's protocol ID
- 2016 - Calcolosi
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Study of Patients Suffering From Nephrolithiasis Undergoing Surgery Using a Minimally Invasive Endoscopic Approach.
- ClinicalTrials.gov ID
- NCT06163313
- Acronym / sponsor ID
- 2016 - Calcolosi
- Conditions
- Calculosis
- Keywords
- calculosis, calculi, endourologia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 17 Sep 2016 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2066 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.
Detailed description
Clinical data will be collected from patients suffering from kidney stones before and after surgery, in order to demonstrate how the endoscopic approach can not only be effective in treating kidney stones but also reduce operative complications.
These data will be collected in a database in order to be able to perform statistical analyzes useful for demonstrating our theory.
Furthermore, data from the surgery will be collected regarding the endoscopic instruments used and the intraoperative findings (site, size, appearance of the stone), degree of calcification of the renal papillae.
All this in order to improve the therapeutic approach to patients suffering from stones and reduce the risk of recurrence over time through the identification of genetic expression patterns that predispose to the expression of the stone phenotype.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calculosis patients | – | Other: Observation of patients suffering from kidney stones who undergo endoscopic surgeryPatients suffering from kidney stones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from kidney stones who undergo endoscopic surgery
Key inclusion criteria (2 listed)
- subjects suffering from kidney stones or tumors of the upper excretory tract >= 18 years
- signature of informed consent
Key exclusion criteria (2 listed)
- subjects < 18 years
- presence of mental or physical disability that may prevent the patient from answering the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of patients suffering from kidney stones who undergo endoscopic surgeryClinical data will therefore be acquired through a collection of medical history, physical examination, blood chemistry and instrumental test reports; | Other | Calculosis patients |
Primary outcome
Clinical data
Time frame: Baseline and after 6 months
Medical history: patient's medical history, past surgical history, family medical history, social history, allergies, and medications; physical examination: vital signs, temperature examination, blood pressure, pulse, and respiratory rate blood chemistry and instrumental test reports: Serum PSA levels, conventional imaging
Eating habits
Time frame: Baseline and after 6 months
Eating habits through an ad-hoc eating habits questionnaire
Prostatic Function
Time frame: Baseline and after 6 months
Prostatic Function through the International Prostatic Symptoms Score questionnaire, IPSS, Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Calculosis
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Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent
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Maintenance of an Antiaggregation by Acetylsalicylic Acid, While a Extracorporeal Lithotripsy Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study
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RecruitingObservational study
Stone Disease of the Urinary Tract in Children
Urinary Lithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Salonia, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calculosis, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Salonia, MD (02 2643 5661, salonia.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical data (time frame: Baseline and after 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.